Aldeyra Therapeutics, Inc. (ALDX) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025. In conjunction with the acceptance of the NDA for review, Aldeyra announced the expansion of its exclusive option agreement with AbbVie, Inc. (ABBV).
On October 31, 2023, Aldeyra entered into an option agreement with AbbVie. Under the terms of the agreement, AbbVie has the option to obtain a co-exclusive license to develop, manufacture, and commercialize reproxalap in the United States.
Upon exercise of the option, AbbVie would pay Aldeyra a $100 million upfront cash payment, less previously paid option fees of $6 million. In addition, Aldeyra would be eligible to receive up to $300 million in regulatory and commercial milestone payments, inclusive of a $100 million milestone payment payable if the FDA approval for reproxalap for dry eye disease is received.
In the United States, Aldeyra would share profits and losses with AbbVie from the commercialization of reproxalap according to a split of 60% for AbbVie and 40% for Aldeyra.
Per the expansion of the option agreement, Aldeyra will initiate certain pre-commercial activities, 60% of which will be paid by AbbVie and 40% of which will be paid by Aldeyra if the option is exercised.
AbbVie has also independently initiated certain pre-commercial planning activities. The parties have also agreed to amend the expiration of the option to 10 business days from the date of FDA approval, if any, of reproxalap for dry eye disease.
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